Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction (LUTO): A Prospective Trial (CYSTO)

  • STATUS
    Recruiting
  • End date
    Aug 1, 2027
  • participants needed
    10
  • sponsor
    Rodrigo Ruano
Updated on 18 October 2022
urinary tract obstruction

Summary

The purpose of the study is to study the outcomes of maternal and fetal patients who are undergoing fetal intervention for severe isolated lower urinary tract obstruction (LUTO).

Details
Condition Lower Urinary Tract Obstructive Syndrome, Lower Urinary Tract Obstruction, Congenital, Bladder Outlet Obstruction, Bladder Outflow Obstruction
Treatment Karl Storz Semi-Rigid TTTS Fetoscopy Instrument Set, Fetoscopes, Fetoscopes, Fetal Cystoscopy
Clinical Study IdentifierNCT03281798
SponsorRodrigo Ruano
Last Modified on18 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Pregnant women
Singleton pregnancy
Oligohydramnios or Anhydramnios
Maternal age ≥ 18 years
Male fetus with LUTO, dilated bladder, "keyhole sign" and bilateral hydronephrosis
Absence of chromosomal abnormalities and associated anomalies
Favorable urine analysis defined as urinary sodium is < 100 milliequivalents per liter (mEq/L), chloride < 90 mEq/L, and osmolality < 200 milliosmoles per kilogram (mOsm/kg) after 20 weeks and in the absence of previous in utero intervention for the disease (vesicoamniotic shunt placement or fetal cystoscopy)
Family have considered and declined the option of termination of the pregnancy at less than 24 weeks
Gestational age at the time of the procedure will be between 16 0/7 weeks and 25 6/7 weeks
Normal karyotype by invasive testing (amniocentesis or Chorionic Villus Sampling (CVS)). Patients declining invasive testing will be excluded
Family meets psychosocial criteria, including sufficient social support and ability to understand requirements of the study
Parents or guardian are willing to provide signed informed consent

Exclusion Criteria

Female fetus
Fetal anomaly unrelated to LUTO
Congenital cardiac anomaly
Placental abnormalities (previa, abruption, accreta) known at time of enrollment
Contraindications to surgery including previous hysterotomy in active uterine segment
Increased risk for preterm labor including short cervical length (<1.5 cm), history of incompetent cervix with or without cerclage, and previous preterm birth
Technical limitations precluding fetoscopic surgery, such as uterine fibroids, fetal membrane separation, uterine anomalies incompatible with fetoscopy
Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy
Maternal medical condition that is a contraindication to surgery or anesthesia
Inability to comply with travel and follow-up requirements of the trial
Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment
Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy
Patients declining invasive testing
Patient does not have health insurance to cover routine clinical care including prenatal care, prenatal ultrasound, amniocentesis, tocolysis, admission, delivery, and fetal vesico-amniotic shunting. The exception will be fetal cystoscopy which is considered an experimental procedure
Family does not meet psychosocial criteria including insufficient
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